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Method for analyzing quality safety of traditional Chinese medicine injection and medicine preparation

An analysis method and injection technology, applied in the direction of drug combinations, pharmaceutical formulas, organic active ingredients, etc., can solve problems such as prone to allergic reactions and irritations, reduce adverse reactions, promote economic production capacity, and improve use safety Effect

Inactive Publication Date: 2014-04-30
潘卫松
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is mostly used clinically for fever, coma, stroke hemiplegia, fever, upper respiratory tract infection, pneumonia, etc., but because it is a compound pharmaceutical extract containing a variety of aminobenzoic acid and protein, it will stimulate the body to produce corresponding antibodies, and it is very prone to allergies reaction

Method used

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  • Method for analyzing quality safety of traditional Chinese medicine injection and medicine preparation
  • Method for analyzing quality safety of traditional Chinese medicine injection and medicine preparation
  • Method for analyzing quality safety of traditional Chinese medicine injection and medicine preparation

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0036] Materials and Methods

[0037] 1 Drug allergy effect of imiquimod as adjuvant

[0038] 1.1 Experimental materials: Qingkailing injection was provided by Guangzhou Mingxing Pharmaceutical Factory, specification 10ml / bottle, batch number 100826; 2,4-dinitrochlorobenzene, chemically pure, purchased from Shanghai Jingchun Reagent Co., Ltd., specification 100g / Bottle, batch number 14676; Acetone was purchased from Sinopharm Chemical Reagent Co., Ltd., specification 500ml / bottle; Adjuvant was Li Kejie (imiquimod cream), purchased from Baihuo Keyi Pharmaceutical Co., Ltd., white cream, Specification 3g: 0.15g, batch number 110201.

[0039] 1.2 Experimental animals: female Hartley guinea pigs, 250-350 g, purchased from Guangzhou Huadong Xinhua Experimental Animal Farm.

[0040]1.3 Preparation of positive substances: weigh 0.2g of 2,4-dinitrochlorobenzene when sensitized, dissolve it in 20ml of acetone to obtain a clear light yellow solution; weigh 0.05g of 2,4-dinitrochlorob...

experiment example 2

[0094] experimental method

[0095] 1 systemic active allergy test (ASA)

[0096] 1.1 Sensitization: Take 6 healthy guinea pigs, both male and female, and inject 0.5ml of Qingkailing injection intraperitoneally, once every other day, for a total of 3 times for sensitization. Weigh and record before the first sensitization.

[0097] 1.2 Challenge: On the 14th and 21st days of sensitization, 3 guinea pigs were administered intravenously for challenge respectively, with a dose of 1.0 ml. Weigh and record before challenge.

[0098] 1.3 Observation: Within 30 minutes after the challenge, did the guinea pigs have any allergic reaction symptoms such as piloerection, dyspnea, and convulsions. If there are two or more of the symptoms of piloerection, sneezing, retching, three consecutive coughs, and dyspnea, or one of convulsions, shock, and death, it is judged that there is an allergic reaction.

[0099] 2 Guinea Pig Maximization Test (GPMT)

[0100] 2.1 Grouping: Take 30 healthy...

experiment example 3

[0141] Anaphylactoid Reaction, also known as Pseudoallergy Reaction, generally refers to the phenomenon that allergic symptoms can be caused by the first administration without going through the process of antibody formation. Anaphylactoid reactions caused by traditional Chinese medicine injections have increasingly become the focus of research on immunotoxicology of traditional Chinese medicine. The lack of a powerful animal model restricts the in-depth study of its non-clinical evaluation and mechanism. Therefore, we conducted a mouse auricle blue staining test to check the efficacy of traditional Chinese medicine injection-like allergic reactions, and initially explored the mechanism of its reaction, in order to establish A high-efficiency animal model can be used to comprehensively and objectively evaluate the allergic reactions caused by traditional Chinese medicine injections, which will lay a foundation for further research on the immunotoxicity of traditional Chinese me...

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Abstract

The invention belongs to the field of medicines, and particularly relates to a method for analyzing quality safety of a traditional Chinese medicine injection and a medicine preparation. According to the invention, the traditional Chinese medicine injection serves as an object of study, a Qingkailing injection, a Chuanhuning injection and a Shenmai injection serve as representatives, a mast cell membrane stabilizer and other anti-allergic medicines are added into the traditional Chinese medicine injection to inhibit various immune toxicity reactions induced by the traditional Chinese medicine injection, and the capability of inducing various hypersensitivities and anaphylactoid reactions is detected, so that the result proves the feasibility of the method for quality control of immunity safety of the traditional Chinese medicine injection. The method provides a novel solution for the main adverse reaction, namely immunotoxicity, of the traditional Chinese medicine injection applied to clinic. A method for detecting the immunity safety control of the traditional Chinese medicine injection is established to control the clinical adverse reactions of the traditional Chinese medicine injection; the mechanism of action is studied, so that the selection and basis are provided for the method for detecting the immunity safety control of the traditional Chinese medicine injection in the new version of pharmacopeia, and the reference is provided for establishing novel guiding principles of immunity safety evaluation for new drugs in China.

Description

technical field [0001] The invention relates to the field of medicine, especially taking traditional Chinese medicine injection as the research object, selecting Qingkailing Injection, Chuanhuning Injection and Shenmai Injection as representatives, by testing their ability to cause hypersensitivity reactions, establishing The detection method of immune safety control of traditional Chinese medicine injection has confirmed that adding anti-allergic drugs such as mast cell membrane stabilizer to the prescription composition of traditional Chinese medicine injection can control the occurrence of clinical immunotoxicity adverse reactions of traditional Chinese medicine injection; and studied its mechanism of action for the following The first edition of the Pharmacopoeia provides the selection and basis for the detection methods of the immune safety control of traditional Chinese medicine injections, and also provides a reference for the formulation of new guidelines for the evaluati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00A61K45/00A61K31/352A61P37/06A61P37/04
Inventor 潘卫松
Owner 潘卫松
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